Relationship Between PFTs and Pdi in DMD

Duchenne Muscular Dystrophy Clinical Trial

Official title:

The Relationship Between Pulmonary Function Measures and Transdiaphragmatic Measures in Duchenne Muscular Dystrophy Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03335384
• Other study ID #: STUDY00001062
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A cross-sectional study to explore the relationship between clinically assessed pulmonary function test (PFT) measures and transdiaphragmatic (Pdi) measures in Duchenne muscular dystrophy (DMD) as well as to explore the relationship between sniff nasal inspiratory pressure (SNIP) and transdiaphragmatic (Pdi) measures in Duchenne muscular dystrophy.

Description:

Two small balloons, which are attached to small, flexible tubes, will be put into the esophagus and stomach through your nose. Each balloon is about 2 inches long (deflated) and about the width of a pencil tip. To reduce any discomfort with this procedure, lidocaine gel or spray will be put into the subject's nose and administered to the back of the throat before the balloon. In addition, swallowing water during the procedure will help to reduce any gagging sensation and will assure that the balloon goes into the esophagus. Proper placement of the catheters will be determined using normal tidal breathing against an occluded mouthpiece with a nose clip. Once proper placement is ensured, the catheters will remain in place during your normal PFT maneuvers. Additionally, while the gastric and esophageal balloon catheters are in place, the subject will be asked to perform a maximal sniff maneuver (SNIP) while one nostril is occluded with a plug containing a distal pressure measurement catheter to measure airway pressure. The distal end of the pressure catheter will be connected to a hand held pressure meter to display peak pressure and to provide you visual feedback. This maneuver will be performed 10 times.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 25 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Duchenne muscular dystrophy

Exclusion Criteria:

• Inability to follow verbal instructions

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Diagnostic Test:
• Esophageal Balloon
Small flexible catheter with deflated balloon at distal end to be inserted into the esophagus through the nose
• Gastric Balloon
Small flexible catheter with deflated balloon at distal end to be inserted into the stomach through the nose
• Nasal Pressure Transducer
Pressure transducer inserted into nasal plug

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Fairview Health Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Pdi	For all subjects Pdi (transdiaphragmatic pressure measures) will be assessed with gastric and esophageal balloons	1 year
Secondary	Evaluation of SNIP	For all subjects, SNIP (sniff nasal inspiratory pressures) will be assessed with a nasal pressure transducer	1 year
Secondary	Evaluation of FVC	For all subjects, FVC (forced vital capacity) will be assessed with spirometry	1 year
Secondary	Evaluation of FEV1	For all subjects, FEV1 (forced expiratory volume in 1 second) will be assessed with spirometry	1 year
Secondary	Evaluation of FEFmax	For all subjects, FEFmax (maximal forced expiratory flow) will be assessed with spirometry	1 year
Secondary	Evaluation of FEF25-75	For all subjects, FEF25-75 (the average forced expiratory flow during the mid (25 - 75%) portion of the FVC) will be assessed with spirometry	1 year
Secondary	Evaluation of FEF50	For all subjects, FEF50 (forced expiratory flow at 50% of FVC) will be assessed with spirometry	1 year
Secondary	Evaluation of MIP	For all subjects, MIP (maximal inspiratory pressure) will be assessed with spirometry	1 year
Secondary	Evaluation of MEP	For all subjects, MEP (maximal expiratory pressure) will be assessed with spirometry	1 year